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Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
Pharma-Grade Enclomiphene now available
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<blockquote data-quote="Cataceous" data-source="post: 146956" data-attributes="member: 38109"><p>These are two separate things. FDA approval means that a drug has been shown to be safe and effective in treating a particular condition, and it may be manufactured and marketed. The approval process is <a href="https://legal-dictionary.thefreedictionary.com/FDA" target="_blank">long, difficult and expensive</a>.</p><p></p><p>Off-label prescribing refers to an <a href="https://www.fda.gov/ForPatients/Other/OffLabel/default.htm" target="_blank">unapproved use of an approved drug</a>. Once a drug is approved then healthcare providers are given discretion in prescribing it for purposes other than what was used to gain approval: "... when they judge that it is medically appropriate for their patient."</p><p></p><p>Ostensibly, unapproved drugs such as enclomiphene and ipamorelin can be prescribed when they are compounded, thus falling less under the FDA's jurisdiction:</p><p>[<a href="http://eureka.criver.com/compounding-and-unapproved-drugs/" target="_blank">1</a>]</p><p>There has been new regulation subsequent to these remarks, which created a new category of compounding pharmacies, still not quite manufacturers, but now subject to FDA inspections and quality standards. Some details <a href="https://compoundingrxusa.com/blog/changes-to-compounding-pharmacy-regulations-eyed-by-the-fda-in-2018/" target="_blank">here</a>.</p><p></p><p>I won't claim this clears everything up, but it at least gives a sense of the regulatory environment.</p></blockquote><p></p>
[QUOTE="Cataceous, post: 146956, member: 38109"] These are two separate things. FDA approval means that a drug has been shown to be safe and effective in treating a particular condition, and it may be manufactured and marketed. The approval process is [URL='https://legal-dictionary.thefreedictionary.com/FDA']long, difficult and expensive[/URL]. Off-label prescribing refers to an [URL='https://www.fda.gov/ForPatients/Other/OffLabel/default.htm']unapproved use of an approved drug[/URL]. Once a drug is approved then healthcare providers are given discretion in prescribing it for purposes other than what was used to gain approval: "... when they judge that it is medically appropriate for their patient." Ostensibly, unapproved drugs such as enclomiphene and ipamorelin can be prescribed when they are compounded, thus falling less under the FDA's jurisdiction: [[URL='http://eureka.criver.com/compounding-and-unapproved-drugs/']1[/URL]] There has been new regulation subsequent to these remarks, which created a new category of compounding pharmacies, still not quite manufacturers, but now subject to FDA inspections and quality standards. Some details [URL='https://compoundingrxusa.com/blog/changes-to-compounding-pharmacy-regulations-eyed-by-the-fda-in-2018/']here[/URL]. I won't claim this clears everything up, but it at least gives a sense of the regulatory environment. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
Pharma-Grade Enclomiphene now available
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